UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018630
Receipt number R000021536
Scientific Title The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer
Date of disclosure of the study information 2015/08/15
Last modified on 2018/08/12 09:10:49

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Basic information

Public title

The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer

Acronym

The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer

Scientific Title

The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer

Scientific Title:Acronym

The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer

Region

Japan


Condition

Condition

Breast Cancer

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To validate a new technique to measure pharmacokinetics and immune response in breast cancer patients treated with T-DM1.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pharmacokinetics and immune response of T-DM1

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

a) Pathologically confirmed breast cancer
b) HER2-positive by IHC or ISH
c) Locally advanced or metastatic/recurrent breast cancer
d) Any prior treatment
e) 20 y.o. and over
f) ECOG performance status 0-2
g) Adequate interval from prior therapy
h) Interval over 2w from prior radiotherapy
i) Adequate baseline organ and marrow function as defined below:
Platelet count >= 100,000mm3
Hemoglobin >= 7.0g/dL
AST and ALT <= 2.5x ULN
Serum bilirubin <= 1.5 x ULN
j) Baseline left ventricular ejection fraction (LVEF) >= 50% by echocardiography
k) Signed written informed consent

Key exclusion criteria

a) Brain metastasis with clinical symptoms
b) Uncontrollable body fluid
c) Concurrent serious disease or condition
Active infection
concurrent serious psychiatric disorder
Ileus, breeding
Uncontrollable angina and mycardial infarction within 3 months, severe heart disease with heart failure
d) pregnant or lactating women
e) Patient considered irrelevant by attending physician for the study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Tamura

Organization

National Cancer Center Hospital

Division name

Breast and Medical Oncology

Zip code


Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

TEL

03-3542-2511

Email

ketamura@ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akihiko Shimomura

Organization

National Cancer Center Hospital

Division name

Breast and Medical Oncology

Zip code


Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

TEL

03-3542-2511

Homepage URL


Email

ashimomu@ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 15 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2015 Year 03 Month 31 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

One year follow-up after completion of recruitment.


Management information

Registered date

2015 Year 08 Month 10 Day

Last modified on

2018 Year 08 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021536


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name